Evaluating the Hexanium TLIF System for treating degenerative disc disease
Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study
This study is testing a new system for back surgery to see if it safely helps people with degenerative disc disease feel less pain and improve their daily activities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 187 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spinevision Sas Industry-sponsored |
| Locations | 6 sites (Bruges and 5 other locations) |
| Trial ID | NCT05997121 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the safety and efficacy of the Hexanium TLIF system in treating patients with degenerative disc disease. It involves both retrospective and prospective subjects, allowing for the collection of data from patients who have already undergone the procedure as well as those scheduled for it. Participants will be monitored for up to 24 months post-surgery, with assessments focusing on back and leg pain, disability levels, and any adverse effects experienced. Key metrics include Visual Analogue Scores (VAS) and the Oswestry Disability Index (ODI).
Who should consider this trial
Good fit: Ideal candidates include skeletally mature patients aged 18 and older who are either planned for or have already received the Hexanium TLIF system implant.
Not a fit: Patients with infections, significant obesity, or other contraindications related to the surgical procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the Hexanium TLIF system, potentially improving treatment options for patients with degenerative disc disease.
How similar studies have performed: While this study is observational and builds on existing surgical techniques, similar approaches in spinal fusion have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021) * Patient of 18 years old or more * Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation Exclusion Criteria: contra-indication * Infection, local to the operative site * Signed of local inflammation * Fever or leukocytosis * Morbid obesity * Pregnancy * Paediatric cases, or patient still having general skeletal growth * Spondylolisthesis unable to be reduced to Grade I * Suspected or documented allergy or intolerance to metal * Any case where the implant components selected for use would be too large or too small to achieve a successful result * Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality * Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance * Prior fusion at the level to be treated * Any case not needing a bone graft or fusion * Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis * Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count * Mental illness * Any patient unwilling to cooperate with post-operative instructions
Where this trial is running
Bruges and 5 other locations
- Clinique du dos Terrefort — Bruges, France (Recruiting)
- Clinique Saint Charles — Lyon, France (Recruiting)
- Hopital privé Clairval — Marseille, France (Recruiting)
- CHRU Nancy — Nancy, France (Recruiting)
- Polyclinique Majorelle — Nancy, France (Recruiting)
- Clinicque Générale Beaulieu — Geneva, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Noel Graziani, Professor — Hopital Privé Clairval
- Study coordinator: Renaud Duchenes
- Email: r.duchenes@spinevision.com
- Phone: +33 6 86 16 61 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.